Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct

Neuromuscular Scoliosis Clinical Trial

— ELASTO  

Official title:

Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04969770
• Other study ID #: APHP210752
• Secondary ID: ID-RCB 2020-A035
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neuromuscular scoliosis are caused by a disorder of the brain, spinal cord or muscular system and often progressive at early age. Conservative treatment is not sufficient to maintain trunk and pelvic balance, and surgical treatment is frequently required. Early definitive spine fusion has the disadvantage of cessation of trunk growth with concomitant effects on lung development. Growth preserving spine surgeries are increasingly used but with high complication rates. The orthopaedic team at Necker Hospital Enfants maladies, Paris, France has developed an innovative fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach. The first 100 patients operated on with this technique had an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence, was necessary thanks to the stability of the correction of the deformities even after skeletal maturation. The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.

Description:

Neuromuscular scoliosis is related to muscle tone abnormalities with a prognosis worsen by damage to the axial and respiratory muscles. The classic treatment for these scoliosis consists of conservative treatment (physiotherapy, bracing), followed by arthrodesis in adolescence. Arthrodesis consists of a global posterior spinal fusion, with a high risk of septic and hemorrhagic complications. In cases of early and rapidly progressive deformities, fusionless techniques allow the preservation of growth while waiting for arthrodesis. However, these techniques have a high rate of complications, particularly of mechanical and infectious origin, which led the orthopedic team at Necker Hospital, Paris, France to develop an innovative technique. This technique is based on bipolar construct, performed by a minimally invasive approach. The first 100 patients operated on have an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence for these patients, was necessary, thanks to the stability of the correction even after skeletal maturation. The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Minor patients between 10 and <18 years old, presenting a neuromuscular pathology, with progressive scoliosis, to undergo for their clinical care a fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach
• Minor patients between 10 and <18 years old, presenting a neuromuscular pathology such as encephalopathy / infantile spinal amyotrophy / myopathy, without progressive scoliosis
• Minor patients between 10 and <18 years old, healthy controls, followed in orthopedics for a pathology other than neuromuscular or spinal deformity
• Written informed consent

Exclusion Criteria:

• No social insurance
• Severe mental retardation or severe dystonia making data acquisition impossible or requiring sedation
• Patients with gastrostomy or tracheostomy

Related Conditions & MeSH terms

• Neuromuscular Scoliosis
• Scoliosis

Intervention

Other:
• Ultrasound elastography (USE)
Visualization of the vertebral disc and the para-vertebral muscles. Intra and inter observer reproducibility analysis carried out for each of the measurements made, by two operators. Patients with instrumented neuromuscular scoliosis: 5 elastographies : preoperatively, then during the usual follow-up consultations with the surgeon every 6 months for 2 years. Patients with neuromuscular pathologies without instrumented scoliosis: 4 elastographies during the usual follow-up consultations with the surgeon every 6 months for 2 years. Healthy control patients without neuromuscular pathology or scoliosis : 1 elastography during an usual consultation.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discal stiffness	Ultrasound elastography (USE) Measurements performed in the transverse plane of L3-L4 intervertebral disc. A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e., 30 images) is recorded. The average of these measurements is reported.	2 years
Primary	Paravertebral muscular stiffness	Ultrasound elastography (USE) Measurement performed in the longitudinal plane, in the axis of muscular fibers and in the middle of multifidus muscle.; A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e. 30 images) is recorded. The average of these measurements is reported in rest and passive stretching position, on the right side and on the left side.	2 years
Secondary	Parameters influencing the progressive stiffening of the spine	Research and description of clinical parameters influencing the progressive stiffening of the spine, e.g. , age, etiology, spinal deformity and correction, BMI	2 years
Secondary	Biomechanical characteristics of the construct	Influence of spinal stiffness on biomechanical characteristics of the construct : distance between the rods and the spine, causing an osteo-inductive process	2 years
Secondary	Occurrence of rod fracture	Occurrence or not of a rod fracture on X-rays	2 years